Job Description
Process Engineering SME / Lead – API / Drug Substance
- Industry: Pharmaceutical / API Manufacturing
- Function: Process Engineering
AMTSOL is seeking an experienced Process Engineering SME / Lead – API / Drug Substance to provide technical leadership and engineering design support for a major pharmaceutical manufacturing project.
The role will work closely with engineering design contractors, project teams, equipment vendors, SHE, GMP, C&Q, and other stakeholders to ensure process designs are technically compliant, practical, safe, maintainable, and aligned with project cost and schedule requirements.
Key Process Areas
- The scope may include:
- Chemical Warehouse
- Material Transfer & Logistics
- Purification Systems – Chromatography & Evaporation
- Freeze Dryers
- Process Reactors
- Filter Dryers
- Solvent Break Tanks supporting Chromatography
- Associated Mechanical Process Packages
Key Responsibilities
- Provide technical leadership and engineering design support for API / Drug Substance process systems
- Translate project requirements into Project Technical Requirements Specifications and engineering deliverables.
- Develop and review URS, ensuring CPP, CQA, CMA, GMP, GEP, SHE, and C&Q requirements are appropriately addressed.
- Review engineering contractor designs, drawings, calculations, specifications, and technical submissions.
- Define and align required design deliverables across Basic Design and Detailed Design stages.
- Participate in Design Assurance activities and maintain technical alignment throughout the project.
- Support technical package strategy, contractor/vendor prequalification, bid evaluation, and equipment selection.
- Participate in SHE and technical risk assessments and ensure appropriate mitigations are incorporated into the design.
- Identify value engineering opportunities while maintaining compliance, operability, cost, and schedule objectives.
- Provide technical guidance to Work Package Owners and support resolution of engineering and construction queries.
- Support development of redundancy strategy, maintenance philosophy, sustainability requirements, and project planning
- Act as the technical SME for assigned API process systems through design and project delivery.
Candidate Profile
- Strong pharmaceutical API / Drug Substance process engineering background.
- Good knowledge of process equipment such as reactors, chromatography, evaporation, freeze dryers, filter dryers, and material transfer systems.
- Experience supporting pharmaceutical CAPEX / facility engineering projects.
- Strong experience with engineering design reviews, technical specifications, URS, and equipment packages.
- Experience working with engineering design contractors and equipment vendors.
- Strong understanding of GMP, GEP, SHE, C&Q, and pharmaceutical engineering requirements.
- Exposure to procurement strategy, technical bid evaluation, and vendor selection.
- Strong practical problem-solving, technical leadership, and stakeholder-management skills.
Preferred Background:
Senior Process Engineer / Process SME / API SME / Drug Substance SME / Process Engineering Lead.
